Risk of Ectopic Pregnancy and Variation of Luteal Estradiol and Progesterone Levels in IVF

Overview

This study evaluates the increased risk of ectopic pregnancy associated with marked variation of estradiol during the early luteal phase and high progesterone on hCG day in IVF.

Full Title of Study: “Retrospective Cohort Study of Increased Risk of Ectopic Pregnancy Associated With Marked Variation of Estradiol During the Early Luteal Phase and High Progesterone on hCG Day in IVF”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: May 2016

Detailed Description

This is a retrospective cohort study of 578 patients who had no risk of EP (672 fresh transfer IVF cycles) between January 2005 and December 2014. Few studies have reported the relation between hormonal levels and ectopic pregnancy (EP) in IVF. Investigators describe EP incidence according to estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7) or their variation between both days.

Interventions

  • Other: Analysis of Ectopic Pregnancy incidence
    • Collect retrospectively data. Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7)

Arms, Groups and Cohorts

  • First quartile
    • No drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7).
  • Second quartile
    • No drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7).
  • Third quartile
    • No drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7)
  • Fourth quartile
    • No drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7)

Clinical Trial Outcome Measures

Primary Measures

  • Ectopic pregnancy rate
    • Time Frame: Up to 108 months

Participating in This Clinical Trial

Inclusion Criteria

  • Normal Fallopian tubes in HSG and /or laparoscopy – Normal Uterus: Abscence of myomas and Müllerian anomalies . Exclusion Criteria:

  • Previous Ectopic Pregnancy . – Recurrent Abortion . – Tubal Factor : pelvic inflammatory disease, Hydrosalpinx – Previous abdominal surgery (except laparoscopy) . – Prior Peritonitis – Smoking (at least 1 cigarette/day) .

Gender Eligibility: Female

Minimum Age: 25 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • IVI Vigo
  • Collaborator
    • Instituto Valenciano de Infertilidad, IVI VALENCIA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elkin Muñoz, Principal Investigator, IVI Vigo

References

Bosch E, Labarta E, Crespo J, Simon C, Remohi J, Jenkins J, Pellicer A. Circulating progesterone levels and ongoing pregnancy rates in controlled ovarian stimulation cycles for in vitro fertilization: analysis of over 4000 cycles. Hum Reprod. 2010 Aug;25(8):2092-100. doi: 10.1093/humrep/deq125. Epub 2010 Jun 10.

Paltieli Y, Eibschitz I, Ziskind G, Ohel G, Silbermann M, Weichselbaum A. High progesterone levels and ciliary dysfunction–a possible cause of ectopic pregnancy. J Assist Reprod Genet. 2000 Feb;17(2):103-6. doi: 10.1023/a:1009465900824.

Citations Reporting on Results

Cobo A, Bosch E, Alvarez C, de los Santos MJ, Pellicer A, Remohi J. Effect of a sharp serum oestradiol fall before HCG administration during ovarian stimulation in donors. Reprod Biomed Online. 2007 Aug;15(2):169-74. doi: 10.1016/s1472-6483(10)60705-5.

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